(2 pg. article)The Bay State’s top public health official today announced the appointment of three new members to the scandal-plagued Massachusetts Board of Pharmacy which oversaw the state’s pharmacy industry during a time when so-called compounding pharmacies grew into industry giants and at least one of those companies, New England Compounding Center, has been blamed for a nationwide outbreak of deadly fungal meningitis.More...

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" Everyone is entitled to his own opinion, but not his own facts." - Daniel Moynihan

Many of the 13,000 or so people who haven’t been sickened by contaminated pain injections from the pharmacy at the center of the fungal meningitis outbreak may have infections they don’t know about, federal health officials warned on Thursday.Patients who got steroid injections from one of three contaminated batches should check back with their doctors if they have any symptoms at all, officials with the Centers for Disease Control and Prevention said -- and doctors should consider running magnetic resonance imaging (MRI) scans to check for infections.Researchers in three of the 19 affected states ran an experiment in which they did MRIs on 128 patients who had not been diagnosed with infections before. They all had new or worsening symptoms such as pain at the injection site. More than half of them -- 52 percent -- had MRI evidence of some type of infection, including abscesses, a type of nerve inflammation called arachnoiditis or even infections of the bone in the spine.“These findings demonstrate that among patients with no previous evidence of infection, and with new or worsening symptoms at or near the site of their injection, more than 50 percent had findings suggestive of a localized spinal or paraspinal infection,” CDC wrote in a health alert sent to doctors.The outbreak of fungal meningitis has made at least 620 people sick and killed 39 of them, and CDC says to expect more infections. It’s been traced to a single pharmacy, the New England Compounding Center (NECC) in Framingham, Mass. The pharmacy has been closed and all of its products recalled, but the crisis has prompted a Congressional investigation of how regulators allowed NECC to continue operating. ::snipping2::

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" Everyone is entitled to his own opinion, but not his own facts." - Daniel Moynihan

The attack rate in the continuing meningitis outbreak is relatively low, with fewer than five exposed people in 20 having developed the disease, researchers reported.

Despite that and some variation in clinical presentation, it's "one of the largest outbreaks of healthcare–associated fungal meningitis reported to date" in the U.S., according to Rachel Smith, MD, of the CDC in Atlanta, and colleagues.

Smith and colleagues paint a picture of "substantial morbidity and mortality" mitigated by a rapid public health response that alerted physicians and patients to the evolving threat, in a preliminary report on the outbreak appearing online in the New England Journal of Medicine.

Indeed, the NEJM paper is "a snapshot of something that's still happening" and it's too early to make many definitive statements about the outbreak, Smith told MedPage Today.

Nonetheless, one key implication is that "it is imperative that steps are taken" to make sure that compounded medications labeled as sterile actually are sterile, she and colleagues concluded.

That's because the outbreak – with 620 cases and 39 deaths as of Dec. 17 -- has been linked to an injectable steroid, preservative-free methylprednisolone acetate, made by the New England Compounding Center in Framingham, Mass.More...

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" Everyone is entitled to his own opinion, but not his own facts." - Daniel Moynihan

As part of the Year in Review series, MedPage Today reporters are revisiting major news stories and following up with an analysis of the impact of the original report, as well as subsequent news on the topic. Here's what's happened with the fungal meningitis outbreak since we published our first report.

The fungal meningitis outbreak that made headlines in the fall was "unprecedented," in the words of the of the clinicians at the eye of the storm.

What's more, "we're not out of the woods yet," said Tom Chiller, MD, deputy director of the CDC's mycotic diseases branch.More...Video at Link

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" Everyone is entitled to his own opinion, but not his own facts." - Daniel Moynihan

The pharmacy at the heart of the fungal meningitis outbreak says a cleaning company it hired should share the blame for the tainted steroid injections that caused more than 600 illnesses in 19 states, killing 39 people.

The New England Compounding Pharmacy, which made the fungus-tainted drugs, sent a letter to UniFirst Corp., which provided once-a month cleaning services to the Framingham, Mass., lab, “demanding” it indemnify NECC for the meningitis outbreak, according to a UniFirst filing with the Securities and Exchange Commission.“Based on its preliminary review of this matter, the company believes that NECC’s claims are without merit,” UniFirst wrote in its quarterly filing.The New England Compounding Center recalled 17,000 vials of tainted steroid injections on Sept. 26 before recalling all drugs and shutting down on Oct. 6.The Food and Drug Administration investigated NECC’s lab and found that a quarter of the steroid injections in one bin contained “greenish black foreign matter,” according to the report. The FDA also identified several cleanrooms that had bacterial or mold overgrowths.UniFirst’s UniClean business cleaned portions of the NECC cleanrooms to NECC’s specifications and using NECC’s cleansing solutions, UniFirst spokesman Adam Soreoff said in a statement. It provided two technicians once a month for about an hour and a half.“UniClean was not in any way responsible for NECC’s day-to-day operations, its overall facility cleanliness, or the integrity of the products they produced,” Soreoff said. “Therefore, based on what we know, we believe any NECC claims against UniFirst or UniClean are unfounded and without merit. ”NECC was not immediately available for comment.The House of Representatives subpoenaed Barry Cadden, who owns NECC, to a hearing in Washington, D.C. on Nov. 14. He declined to testify when members of Congress pressed him on his role in ensuring that the drugs his company produced were safe and sterile.“On advice of counsel, I respectfully decline to answer on the basis of my constitutional rights and privileges including the Fifth Amendment of the Constitution of the United States,” he said at the hearing.Members of Congress also questioned whether the FDA could have prevented the outbreak.More...

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" Everyone is entitled to his own opinion, but not his own facts." - Daniel Moynihan

BOSTON (AP) -- A Justice Department official is arguing that an independent trustee must be chosen to oversee the bankruptcy case of a Massachusetts pharmacy linked to a deadly meningitis outbreak.U.S. Trustee William Harrington says in a filing Tuesday that an accountant chosen by the New England Compounding Center to lead it through Chapter 11 proceedings is "hopelessly conflicted."He says that's because Keith Lowey was appointed by NECC's board and the board has the power to fire him at any time.Harrington also argued the company's "gross mismanagement" meant an independent trustee was needed to protect the interests of the NECC's creditors. ::snipping2::

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" Everyone is entitled to his own opinion, but not his own facts." - Daniel Moynihan

The drug that has caused 696 fungal infections and 45 deaths over the last six months isn’t one you want sloppy amateurs making.

A long-lasting anti-inflammatory, it is difficult to manufacture in sterile form. Injected into joints or around the spine to relieve pain, it stays in the body for months. It has a bad side effect of suppressing defenses — a real problem if it’s contaminated. If the contaminant is a microscopic fungus, the drug feeds it like fertilizer.

n short, methylprednisolone acetate — an “injectable steroid,” in pharmaceutical parlance — is a prescription for disaster if not made right. A few drug companies make it. So do an unknown number of “compounding pharmacies,” a little-known, lightly regulated shadow world of the American pharmaceutical industry.

And that, recent history suggests, is a problem.One company, New England Compounding Center (NECC) of Framingham, Mass., made tens of thousands of doses of methylprednisolone acetate and two other steroids (betamethasone and triamcinolone) used for similar purposes. It sold them to pain clinics in 23 states, satisfying a demand for preservative-free medicines not available from mainstream drug companies. Last year, samples of all three products — including the deadly lots of methylprednisolone — were found to be contaminated with fungus or bacteria.

The dangers of injectable steroids made by compounding pharmacies have been clear for a while.More...

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" Everyone is entitled to his own opinion, but not his own facts." - Daniel Moynihan

LANSING, Mich. (AP) — The state attorney general on Tuesday sought permission to launch a criminal investigation into a Massachusetts pharmaceutical company linked to a deadly outbreak of meningitis, saying Michigan was at the ‘‘epicenter’’ of pain and death in the case.

Bill Schuette filed a request with the Michigan Court of Appeals for a rare, four-county grand jury to conduct a confidential probe into the New England Compounding Center, the company already accused in dozens of civil lawsuits of producing contaminated steroids that killed 51 people nationwide and sickened more than 700.

If the court agrees to an investigation, a jury of citizens in one of the counties would decide if criminal charges should be brought.More...

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" Everyone is entitled to his own opinion, but not his own facts." - Daniel Moynihan

BOSTON -- Attorneys for creditors of a pharmacy linked to a nationwide meningitis outbreak said Monday they have reached a preliminary settlement that would set up a victim compensation fund worth more than $100 million.

Attorney William Baldiga said the agreement was reached among creditors, bankruptcy trustee Paul D. Moore and the owners and insurers of the New England Compounding Center. The deal needs approval from a bankruptcy judge and likely will be filed in the next few weeks.

The company, based in Framingham, just west of Boston, gave up its license and filed for bankruptcy protection after it was flooded with hundreds of lawsuits from people who received tainted steroid injections.About 750 people in 20 states have developed fungal meningitis, an inflammation of the lining of the brain and spinal cord, or other infections; 64 have died.

The infections were linked to more than 17,600 doses of methylprednisolone acetate steroid injections used to treat back and joint pain that were shipped by NECC to 23 states. FDA investigators last Oct. found mold and fungal contamination in vials of the drugs, and areas used to prepare sterile drugs at the facility.

Michigan, Tennessee and Indiana were hit the hardest by the infections.

A federal investigation of the company started more than a year ago but hasn't resulted in any criminal charges. The company's owners said in a press release announcing the settlement that they deny any liability or wrongdoing but want to play a major role in establishing a fund for people who died or suffered. Victims have until Jan. 15 to file claims.

Baldiga said he expects the fund to grow significantly with contributions from others who may have been sued. He said the settlement was reached over the weekend and those involved wanted to announce it as soon as possible so victims who are considering claims know that there is substantial money available.

The initial $100 million will come from cash contributions by the owners of NECC and proceeds from insurance, tax refunds and the sale of a related business.

Baldiga called it "an important step, but a first step only."Last month, President Barack Obama signed legislation that grants the Food and Drug Administration more regulatory powers over drug compounding pharmacies.

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" Everyone is entitled to his own opinion, but not his own facts." - Daniel Moynihan

BOSTON (AP) - Two co-founders and 12 other former employees of a Massachusetts compounding pharmacy blamed for a fungal meningitis outbreak that killed 64 people were arrested early Wednesday, a spokeswoman for the U.S. attorney's office in Boston said.

Gregory Conigliaro and Barry Cadden, co-founders of the New England Compounding Center in Framingham, were among 14 people arrested at their homes around the state, attorney's office spokeswoman Christina DiIorio-Sterling said.

One of those arrested was Glenn Adam Chin, a former supervisory pharmacist, who had been charged with mail fraud in September.

Tainted steroids manufactured by the pharmacy were blamed for a 2012 outbreak. About 750 people in 20 states developed meningitis or other infections after receiving the contaminated steroids. Michigan, Tennessee and Indiana were the hardest-hit states.The exact charges are expected to be disclosed at a news conference later Wednesday, and all expected to make an initial court appearance later in the day.

The pharmacy gave up its license and filed for bankruptcy protection after it was flooded with hundreds of lawsuits filed by victims and their families.

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" Everyone is entitled to his own opinion, but not his own facts." - Daniel Moynihan